Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

With CDMOs Like This, Who Needs Biotechs?

The question struck like a thunderbolt, writes Chief Editor Louis Garguilo. “Where are CDMOs going with all this?” asked Edward Ahn, CEO, Medipost, Inc., referring to the remarkable growth of some CDMOs. “When CDMOs aim to offer every service, capability, and the requisite capacities for an entire drug life cycle – from discovery to clinic to commercialization – what’s actually left for a biotech sponsor to do?” A forward discussion on an evolving outsourcing dynamic.

GUEST COLUMNISTS

New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.
Facility Considerations When Retrofitting Legacy Sites For ADCs
Antibody-drug conjugate manufacturing requires, among other things, unidirectional flow and air locks for people and materials. Facilities often lack these attributes.
In Vivo's Biggest Threat — Comparison To Old Models
In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.
Managing Supply Chain Risk In Scale-Up And Multisite Trials
Scaling trials across sites can lock in supply risk early. Learn how biologic variability, long lead times, and multisite complexity threaten trials and how to spot warning signs fast.
The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.
Why Use Total Organic Carbon Analysis For Cleaning Validation?
Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.
Global Clinical Supply — Confronting Persistent Challenges With Strategic Action
From regulatory fragmentation to cold chain risks, discover how strategic action, data visibility, and resilient design keep clinical trials on track.
December 2025 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

PHARMA OUTSOURCING WHITE PAPERS

AI Implementation To Enhance Quality
Discover how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.

Solve ATMP Aseptic Filling Challenges With Gloveless Isolators
Aseptic filling for ATMPs demands precision and sterility. Robotic gloveless isolators minimize contamination risk through automation and real-time monitoring, ensuring compliance for personalized therapies.
Metabolite And Nutrient Analysis As Crucial Components For Optimal Upstream Process
Discover how insights into cell metabolism can further enable the development of efficient cell culture processes through tailored nutrient supplementation and monitoring.
Overload Setting – Tricks And Techniques
Learn how a partner company that is committed to assisting manufacturers with calibration and optimal set-point establishment can serve as a valuable resource in achieving optimal tablet production.
Advancing Drug Development With Optimized LC-MS/MS Bioanalysis
Explore the critical role of sample preparation optimization and the application of liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) in bioanalytical method development.
Support Of Scale-Up And Technical Transfer Through Understanding Equipment
See how our expertise in formulation and process development can ensure a seamless scale-up from laboratory to full-scale production of lyophilized injectable products.